Systems and methods for transcorporeal microdecompression

ABSTRACT

Devices, systems, and methods for performing a transcorporeal microdecompression are described. The transcorporeal microdecompression may include a bone void plug allograft and specialized instruments for performing the procedure. This procedure may be performed under navigation and/or with robotic assistance.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/660,135 filed on Oct. 22, 2019, which claims priority to U.S. PatentApplication 62/748,601 filed on Oct. 22, 2018, all of which areincorporated herein in their entirety.

FIELD OF THE INVENTION

The present disclosure relates to surgical devices, systems, and methodsfor spinal procedures, and more particularly, devices, systems, andmethods for spinal procedures involving transcorporealmicrodecompression.

BACKGROUND OF THE INVENTION

Surgeons may perform a transcorporeal microdecompression procedure onthe cervical spine to remove posterolateral pathologies, for example.The procedure may target the removal of one or more disc herniationfragments and/or osteophytes. This procedure may involve drilling achannel through the vertebral body to access the posterior corner of thevertebra near the pathology. As this procedure creates a void in thevertebral body, the surgeon may utilize a plug to fill the anterior halfof the bone to restore some strength to the vertebral body. Someexisting plugs may be made of a brittle ceramic that may be easilyfractured and can be difficult to place.

There is a need for improved plugs, instruments, and/or otherimprovements to ease the performance and improve the outcome of thetranscorporeal microdecompression procedure.

SUMMARY OF THE INVENTION

Embodiments of the present application are generally directed todevices, systems and methods for transcorporeal microdecompression.Although transcorporeal microdecompression procedures are exemplifiedherein, it will be appreciated that the devices, instruments and methodsmay be adapted or modified for other anatomical locations andprocedures.

In accordance with the application, in some embodiments, an implant isprovided for transcorporeal microdecompression. The implant may includea bone void plug extending from a first end to a second end. The firstend may be configured to be inserted into a channel in a vertebra. Thesecond end may have an opening configured to mate with an inserterinstrument. A tapered side wall may connect the first and second ends,and a graft window may extend through the side wall. The tapered sidewall may have a diameter greater at the second end relative to the firstend to help prevent migration through the channel post-op. The implantmay be a single-piece, allograft design.

In accordance with some embodiments, a dedicated inserter may beprovided to more precisely insert the implant and provide for thepossibility of removal. The inserter may have an outer sleeve, a middlesleeve terminating in a tip, the middle sleeve positioned within theouter sleeve, an inner shaft positioned within the middle sleeve, and anactuator configured to move the middle sleeve axially along a length ofthe inserter. The tip may be configured to mate with the opening in theimplant such that when the actuator pushes the middle sleeve forward,the tip is compressed, but when moved back, the inner shaft forces thetip outward, thereby mating with the opening of the implant. Theinserter tip and opening in the implant may form a circular dovetailconnection.

In accordance with some embodiments, a uniplanar drill guide may be usedto select the optimal angle for creating and/or access the channel inthe vertebra. The uniplanar drill guide may have a base having a firstextension portion and a second extension portion connected by a bridgeportion. The first extension portion may extend upwardly and terminatein a first free end. The first free end may have a t-shape with a tootharray positioned on an upper surface of the first free end. The secondextension portion may extend upwardly and terminate in a second freeend, and the second extension portion may define a partially cylindricalcavity configured to guide a temporary fastener. The drill guide mayinclude a fastener configured to temporarily secure the base to thevertebra. The drill guide may include a guide tube movable relative tothe base. The guide tube has a central lumen configured to guide aninstrument to create or access the channel in the vertebra. Movement ofthe guide tube may be controllable by an actuation mechanism having arotating lock arm with a cam surface and a selector pin movable by thecam surface. The selector pin is configured to engage with one or moreteeth of the tooth array on the base to thereby lock an angle of theguide tube. The actuation mechanism may include a linearly moveable pincontrollable by a button. The rotating lock arm may include a firstportion and a second portion provided substantially perpendicular to oneanother. The first portion may have an elongate opening for receivingthe moveable pin, and the second portion may have the cam surfaceconfigured to move the selector pin.

In yet other embodiments, a fixed angle guide may be included to providebetter stability during drilling and allow fine tuning of the channelin-situ. The fixed angle guide may include a base configured to beattached to the vertebral body using a temporary fixation pin or otherfastener. The drill guide tube may be permanently attached to the baseto set both the caudal and lateral angles. The drill guide includes aguide tube rigidly affixed to the base and an extension portionextending upwardly from the base and terminating at a free end. Theextension portion may define a partially cylindrical cavity configuredto guide the temporary fixation pin.

In yet further embodiments, a lockable and adjustable depth stop may beprovided to ensure patient safety. The lockable depth stop may includean outer sleeve, an inner sleeve, and a lock collar. The depth stop maysnap onto the shaft of an instrument, such as a drill, and the depth canbe set by rotating the outer sleeve of the stop. The stop may includeone or more spring fingers on the outer sleeve to engage with one ormore indentations along the inner sleeve. The lock collar may snapbetween unlocked and locked positions.

In some embodiments, robotics systems and/or navigation may be used toaid the surgeon in the transcorporeal microdecompression procedure. Asurgical robot system may include an array having a base configured totemporarily affix to a vertebra, an extension arm extending from thebase and terminating in a fixed array having a plurality of markers, aguide tube, and a ball joint connecting the guide tube to the base. Theball joint may define a spherical hole and the guide tube may have amatching sphere that mates with the spherical hole. When the ball jointis locked, an angle of the guide tube is locked, thereby forming atargeted trajectory through the guide tube. The robot system includes arobot configured to track and/or navigate the array. The robot includesa camera configured to track the plurality of markers. The robot may beconfigured to determine the location and any movement of the markers.The robot may include a software program configured to determine apre-planned angle for the guide tube using one or more pre-operativeand/or interoperative CT and/or MRI scans.

According to further embodiments, methods of performing thetranscorporeal microdecompression procedure may include one or more ofthe following steps: (1) using a robotic and/or navigation system toestablish a pre-planned trajectory for a channel into a vertebra; (2)using a robotic and/or navigation system to position a guide tube alongthe pre-planned trajectory; (3) creating a channel along the pre-plannedtrajectory using the guide tube to form the channel from the anterior tothe posterior side of the vertebra; (4) cleaning out the channel and/ordecompressing the spine; and (5) inserting an implant into the channelcreated during the procedure.

Also provided are kits including implants or plugs of varying shapes andsizes, plates of varying shapes and sizes, fasteners of varying typesand sizes, drill guides, drill depth stops, and other components forinstalling the same and performing the transcorporeal microdecompressionprocedure.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings, wherein:

FIG. 1 is an AP view of a tool for creating an access channel in theanterior aspect of a vertebra according to one embodiment;

FIG. 2 is a lateral view of a tool for burring a posterior wall of thevertebra according to one embodiment;

FIG. 3 is a lateral view of a tool for decompressing the spine accordingto one embodiment;

FIG. 4 is a lateral view of a bone void plug implant inserted into theopening in the vertebra created in FIGS. 1-3 according to oneembodiment;

FIG. 5 is a perspective view of a bone void plug allograft according toone embodiment;

FIG. 6 is a cross-sectional view of the bone void plug allograft shownin FIG. 5;

FIG. 7 is a close-up view of the bone void plug allograft attached to aninserter tool according to one embodiment;

FIG. 8 is an AP view of the bone void plug allograft positioned withinthe void of the vertebra according to one embodiment;

FIG. 9 is a lateral view of FIG. 8;

FIG. 10 is a cross-sectional view of an inserter instrument according toone embodiment;

FIG. 11 is a close-up cross-sectional view of the distal end of theinserter of FIG. 10;

FIG. 12 is a perspective view of a uniplanar drill guide according toone embodiment;

FIG. 13 is a temporary fastener suitable for use with the uniplanardrill guide of FIG. 12;

FIG. 14 is a close-up view of the bottom of the base of the uniplanardrill guide of FIG. 12;

FIG. 15 is a side view of the mechanism for rotating the lock arm of theuniplanar drill guide in a natural, locked state;

FIG. 16 is a side view of the mechanism for rotating the lock arm of theuniplanar drill guide in an unlocked state;

FIG. 17 is a perspective view of a pre-assembled fixed angle guideaccording to another embodiment;

FIG. 18 is a side view of a lockable depth stop positioned on a drillaccording to one embodiment;

FIG. 19 is a close-up perspective view of the lockable depth stop ofFIG. 18;

FIG. 20 is a close-up cross-sectional view of the lockable depth stop ofFIG. 19;

FIG. 21 illustrates a robotic and/or navigational system suitable forassisting with transcorporeal microdecompression procedures;

FIG. 22 further illustrates the surgical robotic system of FIG. 21 inaccordance with an exemplary embodiment;

FIG. 23 is a perspective view of a stable reference array and apolyaxial drill guide configured to be used with navigation and/or arobot guidance system;

FIG. 24 is a close-up view of the polyaxial drill guide of FIG. 23;

FIG. 25 depicts a sagittal view of a CT scan with computer graphicsoverlaid to help the user plan the location, orientation, and trajectoryof an access channel through one or more vertebrae according to oneembodiment;

FIG. 26 depicts an axial view of the CT scan of FIG. 25;

FIG. 27 depicts a sagittal view of a CT scan with computer graphicsoverlaid to help the user select the appropriate detent for theuniplanar drill guide from a surgical planning screen according to oneembodiment;

FIG. 28 depicts an axial view of the CT scan of FIG. 27;

FIG. 29 depicts a sagittal view with the graphic having a differenttrajectory and detent for the uniplanar guide than FIG. 27; and

FIG. 30 depicts an axial view of FIG. 29.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the present application are generally directed todevices, systems and methods for transcorporeal microdecompression. Someembodiments are directed to bone void plugs implants configured toaccept an insertion instrument. In one exemplary embodiment, an implantinserter is a dedicated tool that can be used to more precisely insertthe bone void plug implant. Some embodiments are directed toinstruments, such as a uniplanar drill guide configured to be placedflush with and centered on the anterior wall of the patient's vertebralbody, thereby minimizing the amount of cephalad/caudal toggle. Yet otherembodiments are directed to other improvements including a pre-assembledguide, lockable depth stop, or other suitable devices and instruments toassist with the transcorporeal microdecompression. Some embodiments aredirected to robotics systems and/or navigation equipment and techniquesto improve the transcorporeal microdecompression procedure and results.

Although devices, instruments, and methods are described herein fortranscorporeal microdecompression, it will be appreciated that thedevices, instruments, and methods may be adapted for one or moredifferent anatomical areas and/or different surgical procedures.

According to one embodiment, transcorporeal microdecompression may be aprocedure that allows for early surgical intervention to address earlystage herniation and/or stenosis. Transcorporeal microdecompression maytarget the removal of one or more disc herniation fragments and/orosteophytes through anterior access to the vertebral foramen. FIGS. 1-4depict a method suitable for performing the transcorporealmicrodecompression procedure. FIG. 1 depicts an AP view of a cervicalvertebra 10. In FIG. 1, a first instrument 12 may be used to create anaccess channel 14 through the vertebral body 10. The first instrument 12may include a drill, guide, harvesting mill, and/or other instrumentssuitable to create the channel 14. The access channel 14 may extend fromthe anterior to the posterior side of the vertebra 10. FIG. 2 depicts alateral view of the cervical vertebra 10. A second instrument 16 may beused to burr the posterior wall of the vertebra 10. In FIG. 3, a thirdinstrument 18 may be used to decompress the spine. The third instrument18 may include a dissector, kerrision, decker rongeur, curette or otherinstrument suitable for performing a discectomy and removing fragmentsand/or osteophytes. After the channel 14 is created, cleaned out, andthe spine is decompressed, an implant or plug 20 may be inserted intothe channel 14 to fill at least a portion of the void. As shown, theimplant or plug 20 may fill the anterior portion of the channel 14. Thisprocedure may be used independently or in conjunction with othertechniques. For example, one or more spine fixation plates or integratedplate systems may be used on one or more adjacent levels of the spine.

Turning now to FIGS. 5 and 6, the implant or plug 20 may be a bone voidplug allograft. Unlike prior plugs made from brittle ceramic that easilyfracture, plug 20 may be made of stronger allograft. The bone void plug20 may be a single piece, allograft design having a tapered wall 26, agraft window 28 perpendicular to the cone's axis, and an inserterinterface 30 configured to accept an insertion instrument 32 (e.g., asshown in FIG. 10). The plug 20 may extend from a first end 22 to asecond end 24. The first end 22 may be configured to be inserted intothe channel 14. The second end 24 may be configured to connect to aninsertion instrument 32. Although an allograft implant may be desired,it is possible that other suitable materials, such as PEEK(polyetheretherketone), may also be selected to make the implant.

A tapered side wall 26 connects the first and second ends 22, 24. Thesecond end 24 may have a larger diameter than the first end 22. Thetapered angle of side wall 26 may help to prevent migration of theimplant 20 post-op. In particular, the tapered wall 26 may prevent theplug 20 from migrating through the drilled channel 14 as the largerdiameter of the plug 20 may be oversized with respect to the channel 14.The taper may be up to 6° inclusive (3° per side from central axis),which is considered a locking taper and may help hold the plug 20 inplace. The tapered design may help prevent migration through the channel14, thereby avoiding compression of the neural elements. The graftwindow 28 facilitates fusion through the plug 20 to help incorporate orconnect the allograft plug 20 to the patient's vertebral body. The graftwindow 28 may be filled with harvested autograft or allograft, forexample.

The second end 24 of the plug 20 may include a recess or opening 30configured to engage with an insertion instrument 32. The recess oropening 30 may have a dovetail-type configuration (e.g., a circulardovetail) or other configuration for engaging the insertion instrument32. The inserter connection feature provides for proper placement of theplug 20 and for the ability to remove the plug 20, if necessary. Withemphasis on FIGS. 7-9, the inserter 32 is configured to place plug 20within the channel 14 in bone. If necessary, a mallet may be used togently tap the proximal end of the inserter 32 until the plug 20 isfully inserted. The anterior portion of the plug 20 should be flush withor slightly proud of the anterior wall of the vertebral body 10. FIG. 8depicts an AP view of the bone void plug 20 positioned within the voidof the vertebra 10 and FIG. 9 is a lateral view of FIG. 8. Once the plug20 is in the desired position, the inserter 32 may be released andremoved.

Turning now to FIGS. 10 and 11, the implant inserter 32 is shown inaccordance with one embodiment. The implant inserter 32 may be adedicated tool that can be used to more precisely insert the implant orplug 20. The inserter 32 may be configured to engage with the connectionfeature 30 of the plug 20, thereby allowing for proper placement of theplug 20 and/or the ability for removal of the plug 20. The inserterinterface feature 30 allows for the implant 20 to firmly seat againstthe inserter 32 so that impaction forces are equally distributed to theimplant 20. This feature 30 also allows for pulling on the implant 20 tomove it towards the surgeon (e.g., if over-inserted) or remove theimplant 20 completely from the channel 14.

The inserter 32 includes a handle portion 42, an outer tube or sleeve40, an inner shaft 38, a tube or middle sleeve 34, and an actuatorspring mechanism 44 configured to move the middle sleeve 34 axiallyalong the length of the inserter 32. The middle sleeve 34 terminates ina dovetail tip 36 configured to mate with and match the correspondingopening 30 in the implant 20. The tip 36 is split and naturallycompressed to minimize friction/interference when attaching and/orremoving the implant 20. When the actuator 44 pushes the sleeve 34forward, the tip 36 is compressed, but when sprung back, the inner shaft38 forces the dovetail tip 36 to its nominally dimensioned position,thereby matching and mating with the opening 30 of the implant 20. Theouter sleeve 40 acts as the backstop and ensures distributed forceduring insertion, helping ensure the implant 20 does not break loose.

Turning now to FIGS. 12-16, a uniplanar drill guide 50 is shown inaccordance with one embodiment. More traditional drill guides may limitthe surgeon to one angle during the procedure, which may not beapplicable to every patient. To lessen the quantity of single angledrills guides needed, the uniplanar drill guide 50 allows the surgeon toselect the optimal angle in-situ based on the patient's anatomy. Theselected angle is locked in position unless the user releases it.

As shown in FIG. 12, the uniplanar drill guide 50 includes a base 52, atemporary fastener 54 configured to temporarily secure the base 52 tobone, a guide tube 56 movable relative to the base 52, the guide tube 56having a central lumen 68 configured to guide a drill or otherinstrument to create and/or access the cavity or channel 14 in the bone,and a handle assembly 58 configured to control the uniplanar drill guide50. The handle assembly 58 may include a handle 60 configured to begripped by a surgeon or other operator and at least one arm 62 forengaging with and controlling the base 52 and the tube 56.

The uniplanar drill guide base 52 includes a first portion 70 and asecond portion 72 connected by a bridge portion 74. The bridge portion74 has one or more surfaces configured to engage with the anatomy of theanterior surface of the vertebra 10. The uniplanar drill guide base 52may be placed flush with and centered on the anterior wall of thepatient's vertebral body 10, thus minimizing the amount ofcephalad/caudal toggle. As best seen in FIG. 14, the base 52 may beanchored in place, for example, through a first opening 64 with atemporary fixation screw, pin, or other fastener 54. The base 52 mayinclude a second opening 66 configured to be aligned with the lumen 68through guide tube 56. The base 52 may be anchored in place,additionally or alternatively, for example, with one more spikes 75protruding downwardly from the bridge portion 74. Thus, the base 52 maybe rotationally stabilized with the small spikes 75 on the bottomsurface of the bridge portion 74 that engages with the vertebra 10.Although three pointy spikes 75 are exemplified in FIG. 14, it will beappreciated that any suitable type, numbers, or placement of spikes 75or other protrusions may be selected to improve fixation to the bone.

The uniplanar drill guide base 52 may include one or more indentations76 along the bridge portion 74. If present, the separation of the firstand second portions 70, 72 by one or more indentations 76 may allow forcontouring of the bottom surface of bridge portion 74 to furtheraccommodate the anatomy of the bone. As best seen in FIG. 12, the firstportion 70 of the uniplanar drill guide 50 extends upwardly andterminates in a first free end 78. The free end 78 may form a t-shapeand an upper surface of the free end 78 may include a radial ratchet ortooth array 80. The tooth array 80 may include a plurality of teeth,notches, or detents. The second portion 72 of the uniplanar drill guide50 extends upwardly and terminates in a second free end 82. The secondportion 72 may define a partially cylindrical cavity 84 configured toguide the fixation pin or fastener 154 into position and/or receive aportion of the guide tube 56 to thereby act as a stop when the guidetube 56 is articulated away from first portion 70.

The guide tube 56 extends from a proximal end 86 to a distal end 88which engages and cooperates with base 52. A protrusion, pin 90, orother suitable mechanism may be used to secure the distal end 88 of thetube 56 to the base 52. Movement of the proximal end 86 of the guidetube 56 is controlled by an actuation mechanism 92. The actuationmechanism 92 includes a rotating lock arm 94, a selector pin 96 having atip 98 configured to engage with one or more teeth of the tooth array 80on the base 52, and a moveable pin 100 controllable by a button 102.

As best seen in FIGS. 15 and 16, the rotating lock arm 94 may include afirst portion 104 and a second portion 106 provided substantiallyperpendicular to one another. The rotating lock arm 94 may be pivotableabout a pivot pin 108. The first portion 104 may include an elongateopening 110 configured to receive the moveable pin 100 and the secondportion 106 may include a cam surface 112 configured to move selectorpin 96. The moveable pin 100 may be linearly translatable along an axialdirection of arm 62 by button 102. The selector pin 96 may be springloaded by a spring 114 and linearly translatable from a first position(shown in FIG. 15) to a second position (shown in FIG. 16). When theselector pin 96 is in the first position shown in FIG. 15, the rotatinglock arm 94 is in a natural, locked state, and the selector pin 96 isengage with one or more teeth of the tooth array 80, thereby locking theposition of the guide tube 56. When the selector pin 86 is in the secondposition shown in FIG. 16, the rotating locking arm 94 is in an unlockedstate, and the guide tube 56 is free to move.

The guide tube 56 may have a fixed lateral angle, for example, of 7.5°.The cephalad/caudal angle may be set in-situ by the actuation mechanism92. During operation, by pressing the lock button 102, the rotating lockarm 94 is actuated, thereby freeing the selector pin 96, and moving thedistal tip 98 across the radial ratchet/tooth array 80. The selector pin96 is spring loaded to provide tactile feedback when crossing the teeth80, adjusting the angle of the guide tube 56, and to center the guidetube 56 at a lockable angle. Releasing the lock button 102 springs therotating lock arm 94 back in place, preventing the selector pin 96 frommoving and thus locking the angle of the guide tube 56. The surgeon canset the angle of the guide tube 56, confirm the trajectory withfluoroscopy, readjust the angle if necessary, and confidently drill anoptimal angle for various patients.

The uniplanar guide 50 allows for in-situ angle adjustments to set thecephalad/caudal trajectory of the drill while maintaining a constantlateral angle, which provides a single instrument to set the optimalchannel trajectory regardless of patient anatomy. The angle is lockedunless the unlock button 102 is pressed.

As an alternative to the uniplanar drill guide 50, a fixed angle drillguide 150 is shown in FIG. 17. The fixed angle guide 150 may be suitablefor some patient anatomy when a fixed guide tube 156 is desired. Thefixed angle guide 150 has a base 152 configured to attach to thevertebral body using a temporary fastener 54, one or more spikes 75,and/or other suitable fasteners. The drill guide tube 156 is permanentlyattached to the base 152 to set both the caudal and lateral angles. Anoffset handle 160 is permanently attached to the guide tube 156 to easeinstallation into the patient, provide better stability during drilling,and/or allow fine tuning of the channel 14 in-situ.

The drill guide 150 includes base 152, fastener 54 configured to securethe base 152 to bone, guide tube 156 rigidly affixed to the base 152,the guide tube 156 having a central lumen 168 configured to guide adrill or other instrument to create and/or access the cavity or channel14 in the bone, and handle 160 configured to be gripped by a surgeon orother operator and at least one arm 162 for controlling the base 152 andthe tube 156. The guide base 152 may be placed flush with and centeredon the anterior wall of the patient's vertebral body 10. An extensionportion 172 of the guide 150 may extend upwardly from the base 152 andterminate at a free end 182. The extension portion 172 may define apartially cylindrical cavity 184 configured to guide the temporaryfixation pin or fastener 154 into position.

Turning now to FIGS. 18-20, a lockable depth stop 200 may be used with adrill 202, harvesting mill, or other instrument to ensure the surgeon oruser does not pass a given depth when creating and/or accessing channel14. The depth stop 200 thereby prevents unintentional entry into thespinal canal or other restricted anatomical areas. The drill 202 maycomprise a shaft 204 terminating at a distal end 206 with one or morethreads 208 configured to cut bone, and a proximal end 210 configured toquick connect to a handle 212 having a grip for the surgeon or user. Thedepth stop 200 includes an outer sleeve 214, an inner sleeve 216, and alock collar 222.

The drill depth stop 200 snaps onto the shaft 204 of the drill 212 andthe depth can be set by rotating the outer sleeve 214 of the stop 200.One or more spring fingers 218 on the outer sleeve 214 rides between oneor more indentations or holes 220 in the inner sleeve 216, designatingvarious maximum depths for the drill 202. One or more spring fingers 224on the inner sleeve 216 engages with corresponding indentations ornotches 226 along the shaft 204 of the drill 202. The lock collar 222snaps between unlocked and locked position, thereby allowing the user toselect a depth and ensure it does not adjust during use. By sliding thelock collar 222 towards the handle 212, the depth stop 200 is unlocked,and by sliding the lock collar 222 towards the distal end 206, the depthstop is locked. The depth stop 200 may be adjusted in situ, and may beused to further ensure patient safety

Robotics systems and/or navigation may be used to aid the surgeon in thetranscorporeal microdecompression procedure. Turning now to FIGS. 21 and22, a robot system 300 is shown, which may be suitable for use withtranscorporeal microdecompression. The ability to perform this procedureunder navigation and/or robotic assistance may help to target thepathology directly from imaging based on the best angle trajectory forthe patient.

As seen in FIG. 21, the surgical robot system 300 may include, forexample, a surgical robot 302, one or more robot arms 304, a base 306, adisplay 310, an end-effector 312, for example, including a guide tube314, and one or more tracking markers 318. The surgical robot system 300may include a patient tracking device 316 also including one or moretracking markers 318, which is adapted to be secured directly to thepatient 320 (e.g., to the bone of the patient 320). The surgical robotsystem 300 may also utilize a camera 322, for example, positioned on acamera stand 324. The camera stand 324 can have any suitableconfiguration to move, orient, and support the camera 322 in a desiredposition. The camera 322 may include any suitable camera or cameras,such as one or more infrared cameras (e.g., bifocal orstereophotogrammetric cameras), able to identify, for example, activeand passive tracking markers 318 in a given measurement volume viewablefrom the perspective of the camera 322. The camera 322 may scan thegiven measurement volume and detect the light that comes from themarkers 318 in order to identify and determine the position of themarkers 318 in three-dimensions. For example, active markers 318 mayinclude infrared-emitting markers that are activated by an electricalsignal (e.g., infrared light emitting diodes (LEDs)), and passivemarkers 318 may include retro-reflective markers that reflect infraredlight (e.g., they reflect incoming IR radiation into the direction ofthe incoming light), for example, emitted by illuminators on the camera322 or other suitable device.

FIG. 21 illustrates a potential configuration for the placement of thesurgical robot system 300 in an operating room environment. For example,the robot 302 may be positioned near or next to patient 320. Althoughdepicted near the head of the patient 320, it will be appreciated thatthe robot 302 can be positioned at any suitable location near thepatient 320 depending on the area of the patient 320 undergoing theoperation. The camera 322 may be separated from the robot system 302 andpositioned at the foot of patient 320. This location allows the camera322 to have a direct visual line of sight to the surgical field 326.Again, it is contemplated that the camera 322 may be located at anysuitable position having line of sight to the surgical field 326. In theconfiguration shown, the surgeon may be positioned across from the robot302 but is still able to manipulate the end-effector 312 and the display310.

With respect to the other components of the robot 302, the display 310can be attached to the surgical robot 302 and in other exemplaryembodiments, display 310 can be detached from surgical robot 302, eitherwithin the surgical room with the surgical robot 302, or in a remotelocation. End-effector 312 may be coupled to the robot arm 304 andcontrolled by at least one motor or may be separate from the robot 302and navigated by the surgeon. In exemplary embodiments, end-effector 312can comprise a guide tube 314, which is able to receive and orient asurgical instrument used to perform surgery on the patient 320. Althoughgenerally shown with a guide tube 314, it will be appreciated that theend-effector 312 may be replaced with any suitable instrumentationsuitable for use in surgery. In some embodiments, end-effector 312 cancomprise any known structure for effecting the movement of the surgicalinstrument in a desired manner.

When affixed to the robot 302, the surgical robot 302 is able to controlthe translation and orientation of the end-effector 312. The robot 302is able to move end-effector 312 along x-, y-, and z-axes, for example.The end-effector 312 can be configured for selective rotation about oneor more of the x-, y-, and z-axis, and a Z Frame axis (such that one ormore of the Euler Angles (e.g., roll, pitch, and/or yaw) associated withend-effector 312 can be selectively controlled). In some exemplaryembodiments, selective control of the translation and orientation ofend-effector 312 can permit performance of medical procedures withsignificantly improved accuracy compared to conventional robots thatutilize, for example, a six degree of freedom robot arm comprising onlyrotational axes. For example, the surgical robot system 300 may be usedto operate on patient 320, and robot arm 304 can be positioned above thebody of patient 320, with end-effector 312 selectively angled relativeto the z-axis toward the body of patient 302.

In some exemplary embodiments, the position of the surgical instrumentcan be dynamically updated so that surgical robot 302 can be aware ofthe location of the surgical instrument at all times during theprocedure. Consequently, in some exemplary embodiments, surgical robot302 can move the surgical instrument to the desired position quicklywithout any further assistance from a physician (unless the physician sodesires). In some further embodiments, surgical robot 302 can beconfigured to correct the path of the surgical instrument if thesurgical instrument strays from the selected, preplanned trajectory. Insome exemplary embodiments, surgical robot 302 can be configured topermit stoppage, modification, and/or manual control of the movement ofend-effector 312 and/or the surgical instrument. Thus, in use, inexemplary embodiments, a physician or other user can operate the system300, and has the option to stop, modify, or manually control theautonomous movement of end-effector 312 and/or the surgical instrument.Further details of surgical robot system 300 including the control andmovement of a surgical instrument by surgical robot 302 can be found inU.S. Patent Publication No. 2017/0239007, which is incorporated hereinby reference in its entirety for all purposes.

The robotic surgical system 300 can comprise one or more trackingmarkers 318 configured to track the movement of robot arm 304,end-effector 312, patient 320, and/or the surgical instrument in threedimensions. In exemplary embodiments, a plurality of tracking markers318 can be mounted (or otherwise secured) thereon to an outer surface ofthe robot 302, such as, for example and without limitation, on base 306of robot 302, on robot arm 304, or on the end-effector 312. In exemplaryembodiments, at least one tracking marker 318 of the plurality oftracking markers 318 can be mounted or otherwise secured to theend-effector 312. One or more tracking markers 318 can further bemounted (or otherwise secured) to the patient 320. In exemplaryembodiments, the plurality of tracking markers 318 can be positioned onthe patient 320 spaced apart from the surgical field 326 to reduce thelikelihood of being obscured by the surgeon, surgical tools, or otherparts of the robot 302. Further, one or more tracking markers 318 can befurther mounted (or otherwise secured) to the surgical tools (e.g.,drill, screwdriver, dilator, implant inserter, or the like). Thus, thetracking markers 318 enable each of the marked objects (e.g., theend-effector 312, the patient 320 and the surgical tools) to be trackedby the robot 302. In exemplary embodiments, system 300 can use trackinginformation collected from each of the marked objects to calculate theorientation and location, for example, of the end-effector 312, thesurgical instrument (e.g., positioned in the tube 314 of theend-effector 312), and the relative position of the patient 320.

The markers 318 may include radiopaque or optical markers. The markers318 may be suitably shaped include spherical, spheroid, cylindrical,cube, cuboid, or the like. In exemplary embodiments, one or more ofmarkers 318 may be optical markers. In some embodiments, the positioningof one or more tracking markers 318 on end-effector 312 can maximize theaccuracy of the positional measurements by serving to check or verifythe position of end-effector 312. Further details of surgical robotsystem 300 including the control, movement and tracking of surgicalrobot 302 and of a surgical instrument can be found in U.S. PatentPublication No. 2017/0239007, which is incorporated herein by referencein its entirety for all purposes.

Exemplary embodiments include one or more markers 318 coupled to thesurgical instrument. In exemplary embodiments, these markers 318, forexample, coupled to the patient 320 and surgical instruments, as well asmarkers 318 coupled to the end-effector of the robot 302 can compriseconventional infrared light-emitting diodes (LEDs) or an Optotrak® diodecapable of being tracked using a commercially available infrared opticaltracking system such as Optotrak®. Optotrak® is a registered trademarkof Northern Digital Inc., Waterloo, Ontario, Canada. In otherembodiments, markers 318 can comprise conventional reflective spherescapable of being tracked using a commercially available optical trackingsystem such as Polaris Spectra. Polaris Spectra is also a registeredtrademark of Northern Digital, Inc. In one embodiment, the markers 318coupled to the end-effector 312 are active markers which compriseinfrared light-emitting diodes which may be turned on and off, and themarkers 318 coupled to the patient 320 and the surgical instrumentscomprise passive reflective spheres.

In some embodiments, light emitted from and/or reflected by markers 318can be detected by camera 322 and can be used to monitor the locationand movement of the marked objects. In alternative embodiments, markers318 can comprise a radio-frequency and/or electromagnetic reflector ortransceiver and the camera 322 can include or be replaced by aradio-frequency and/or electromagnetic transceiver.

FIG. 22 illustrates surgical robot system 300 with robot 302 and camerastand 324, in a docked configuration. Robot 302 includes display 310,upper arm 303, lower arm 304, end-effector 312, vertical column 308,casters 330, cabinet 332, tablet drawer 334, connector panel 336,control panel 338, and ring of information 340. FIG. 22 illustrates thesurgical robot system 300 in a docked configuration where the camerastand 324 is nested with the robot 302, for example, when not in use. Itwill be appreciated by those skilled in the art that the camera 322 androbot 302 may be separated from one another and positioned at anyappropriate location during the surgical procedure, for example, asshown in FIG. 21. One or more of the following U.S. Patent Publicationsdescribe suitable robotic and/or navigation systems in more detail:2017/0079727; 2017/0007334; 2017/0172669; 2017/0239007; 2016/0256225;2016/0278875; and 2016/0220320. These publications and any othersidentified herein are incorporated by reference in their entireties forall purposes.

Turning now to FIGS. 23-24, one or more specialized devices may furtherimprove the robotics system and/or navigation for use with thetranscorporeal microdecompression procedure. One challenge withnavigation and robotics is having a stable reference array. FIG. 23depicts a patient reference array, dynamic reference base (DRB), orarray 400 that anchors directly to the vertebral body 10. The array 400may include one or more markers 318 configured to be tracked by camera322 such that robot 302 can identify and determine the position andmovement of the markers 318 in three-dimensions in real time. Array 400may include a variable angle drill guide 402, similar to uniplanar drillguide 50 or fixed angle drill guide 150 described herein, such that oneor more instruments (e.g., drills) may be guided along a trajectory tocreate and/or access channel 14 in the vertebra 10.

The array 400 may include a base 404 having one or more surfacesconfigured to engage with the anatomy of the anterior surface of thevertebra 10. The base 404 may be placed flush with and centered on theanterior wall of the patient's vertebral body 10. Similar to uniplanardrill guide 50 or fixed angle drill guide 150, the base 404 may beanchored in place, for example, through a first opening 406 with atemporary fixation screw, pin, or other fastener 54. The base 404 mayinclude a second opening configured to be aligned with the lumen 408through guide tube 410. The base 404 may be anchored in place,additionally or alternatively, for example, with one more spikes 75protruding downwardly from the base 404.

An extension arm 412 may extend from the base 404 and may be configuredto hold a fixed array 414 of markers 318. The extension arm 412 may becurved or contoured to keep the array 414 out of the working area of theguide tube 410. The array 414 and placement of markers 318 may beselected such that the robot 302 knows the type of array 400,instrument, and/or procedure to be performed. Although four fixedmarkers 318 are exemplified in array 414, it will be appreciated thatany suitable number and placement of markers 318 may be used.

The array base 404 may include a ball joint 416 for a polyaxial drillguide 410 to attach to. The ball joint 416 may be used with navigationwhile the standalone array 400 could be used a robot guidance system,whose arm 304 could hold the trajectory of the instrument (e.g., drill).

As best seen in FIG. 24, the variable angle drill guide 402 may be usedto set the trajectory with navigation and lock the selected trajectorybetween pilot drilling, channel drilling, and/or any other operationswhile drilling the main trajectory. The base 404 is attached to thevertebral body with a fixation screw 54. The ball joint 416 defines aspherical hole 418 and the guide 410 has a matching sphere 420 at tip422 that fits into the hole 418, for example, due to one or more cuts424 that allow the tip 422 to expand and/or contract. The inner sleeve425 utilizes a tapered tip 426 to force the sphere 420 into contact withthe base, thus locking the ball joint 416 and the corresponding drilltrajectory. The proximal end 428 of the guide 402 contains a lockingmechanism that may include a threaded set screw or pin 430, for example.Alternatively, the locking mechanism may include a ratcheting sleeve toallow forward locking motion but resist loosening, a lever/cam mechanismsimilar to a bicycle wheel clamp, or of other suitable design to lockthe trajectory of the guide tube 410.

Using robotic and/or navigation for creating the initial channeltrajectory helps minimize the amount of manual flaring out to access thepathology, thus preserving more bone towards the posterior wall of thevertebral body and minimizing the time of burring/cutting bone. Bettertargeting with robotics and/or navigation may also allow for saferchannel creation for patients with abnormal physiology.

The patient reference array or dynamic reference base (DRB) 400 withattached adjustable guide tube 402 may be rigidly mounted to thevertebral body 10 and then registered with the robot 302. After which,the adjustable guide tube 410 may be used to perform the transcorporealmicrodecompression procedure. It is contemplated that this array 400 mayalso have one or more linear adjustment mechanisms to allow offset ofthe entry point of the adjustable guide tube 410. One linear adjustmentmechanism to adjust the rostrocaudal entry point may be adequate sincethe surgeon may be able to assess the correct entry position laterally,or no linear adjustment mechanism may be necessary if there is a rangeof acceptable positions for performing the procedure and the surgeon cansuccessfully position the device to be somewhere within this range.

The robot 302 may utilize interoperative and/or pre-operative CT scansand/or MM images. A CT (computerized tomography) uses multiple x-rays,taken at different angles, to produce the cross-sectional imaging. AnMRI (magnetic resonance imaging) uses magnetic fields and radiofrequencies to produce the imaging. According to one embodiment,workflow for a navigated procedure using the DRB/drill guide 400 andintraoperative CT may be as follows:

-   -   1. Expose the anterior cervical spine and attach the DRB/drill        guide tool 400 with two or more screws 54 into the vertebral        body 10 or adjacent vertebral bodies. Rough feedback on best        location to attach the device could be direct visualization or        fluoroscopy.    -   2. Temporarily mount an ICT (intra-op CT registration) fixture        or an outrigger with radio-opaque fiducials 318 at a known        location near the DRB 400.    -   3. Collect an intraoperative CT scan using O-arm or other        imaging device.    -   4. Register tracking to the ICT and transfer this registration        to the DRB. Remove the ICT.    -   5. With registration complete, insert a navigated tool into the        guide tube 410. With guide tube unlocked, angle the navigated        tool while watching CT image slices in planes defined by the        navigated tool until the desired trajectory is needed. Adjust        the linear offsets if necessary to position the tool where        needed.    -   6. While holding navigated tool in correct location, lock the        angular and linear mechanisms on the guide tube 410.    -   7. At this navigated position, assess implant length and drill        stop positions for the procedure.    -   8. Perform microdecompression procedure through the guide tube        410, navigating tools where possible.

If no linear adjustment mechanism is present, the above workflow isstill possible but in Step 5, the user may adjust the tube position tothe best angular orientation for the procedure, understanding theconstraints imposed by where the device was mounted and if necessary,removing and reattaching the device in a different location.

If preoperative CT is to be used, the workflow may differ slightly andmay be as follows:

-   -   1. Expose the anterior cervical spine and attach the DRB/drill        guide tool 400 with two or more screws 54 into the vertebral        body 10 or adjacent vertebral bodies. Rough feedback on best        location to attach the device could be direct visualization or        fluoroscopy.    -   2. Collect a pair of fluoroscopic images with a tracked        fluoroscopy unit. The tracking array on the fluoroscopy unit and        the DRB array 400 may both be visible at the time each fluoro        shot is collected. Register tracking to a preoperative CT or MRI        by performing the bone contour matching of fluoro shots to        digitally reconstructed radiographs.    -   3. With registration complete, insert a navigated tool into the        guide tube 410. With guide tube unlocked, angle the navigated        tool while watching CT/MRI image slices in planes defined by the        navigated tool until the desired trajectory is needed. Adjust        the linear offsets if necessary to position the tool where        needed.    -   4. While holding navigated tool in correct location, lock the        angular and linear mechanisms on the guide tube 410.    -   5. At this navigated position, assess implant length and drill        stop positions for the procedure.    -   6. Perform microdecompression procedure through the guide tube,        navigating tools where possible.

By utilizing surgical planning software, navigation and robotics, it maybe easier and safer to prepare the access channel 14, size the bone plug20, and insert the bone plug 20 than may be possible using hand toolsand fluoroscopy.

In some further embodiments, navigated robotics and software tools canaugment or replace a drill guide. Turning now to FIGS. 25-26, onesoftware tool could allow the surgeon to virtually select the locationand orientation of the diagonal channel 14 through the vertebra 10 on aCT or MRI image 310 a, 310 b, for example.

FIG. 25 shows a sagittal view 310 a of a CT scan and FIG. 26 shows anaxial view 310 b of a CT scan with computer graphics overlaid to helpthe user plan the trajectory for the planned access channel 14 a to thecervical spinal canal. Axes corresponding to true rostrocaudal, lateral,and anteroposterior directions are drawn on the CT slices and thedisplayed planes intersect the planned channel 14 a. In one embodiment,the diameter of the channel 14 a may be fixed at 6 mm, and there may bea fixed lateral angulation of 7.5° relative to midline of the plannedchannel 14 a. It will be appreciated that the trajectory, position, andorientation of the planned channel 14 a may be modified or moved by thesurgeon during pre-planning or in real time during the surgicalprocedure.

In yet another embodiment, the software tools may be used in conjunctionwith the uniplanar drill guide 50, for example. FIGS. 27-30 show anembodiment of a software feature that may allow the user to select theappropriate tooth or detent for the uniplanar drill guide 50 from thesurgical planning screen 310 of the robot 302. The user adjusts theplacement of the foot of the drill guide 50 relative to the spine orthat placement is auto-set based on image processing and as the useradjusts the slice plane, the corresponding drill guide position isdisplayed.

The software tools may assist in pre-planning or during surgery to aidin selection of the desired notch of the tooth array 80 on the uniplanarguide 50. As best seen in FIGS. 27-30, an adjustable interface allowsthe user to select the angle of the planned channel 14 a through thevertebra 10, and then provides feedback on the appropriate notch on theuniplanar drill guide 150. Feedback could be visual, showing arepresentation 80 a of the tooth array 80 and specific notch where thetool should be set, or could be numerical, specifying the notch numberthat the drill guide 150 should be set to. Such a software interfacealso allows the implant length to be selected and the distance fromentry to spinal canal to be accurately measured, allowing the lockabledepth stop 200 to be accurately set, for example.

In yet further embodiments, through navigated robotics, the drill guidecould be eliminated and instead, the robot 302 could hold a guide tube314 at the necessary location for the surgeon to drill through. Surgicalplanning could be similar to FIGS. 25-26 but once the location of theimplant is set, the robot 302 may automatically position itself adjacentto the surgical site in the correct location and orientation to allowdrilling and device insertion. Software can enable the robot 302 toautomatically position the guide tube 314 along the required trajectorybut away from the patient by the exact amount so that the drill or othertool “bottoms out” once the appropriate depth is reached. This featureis an additional safety measure to prevent accidentally drilling intothe spinal canal. A drill or insertion tool with tracking array mayallow the user to watch the location of the drill and the position ofthe implant during drilling and implant placement respectively.

To prevent skiving of the drill tip along the bone surface when creatingthe access channel 14, it may be desirable for the drill guide to remainin contact with the anterior bony surface of the spine during drilling.It is therefore contemplated that a lockable drill guide, similar todrill guide 200, may be utilized. The drill guide may have an adjustabletelescoping mechanism whose function is to set the amount by which thedrill can exit the bottom of the guide tube when the drill housingcontacts the proximal end of the drill guide. The drill guide may besized so that its outer diameter is in close tolerance with the innerdiameter of the robot's guide tube. The entire drill guide may thenslide through the robot's guide tube 314 and the surgeon may proceedwith drilling, aware that the drill will bottom out on the nested guidetube when target depth is reached. Additionally, the depth of the toolmay be navigated and displayed on the robotic system 300.

According to yet further embodiments, the robot 302 may further assistwith the transcorporeal microdecompression. A potentially challengingportion of the transcorporeal microdecompression procedure is placementof the graft after decompression is complete. Forcing the graft intoplace may require malleting, which may be dangerous in the patient'sexposed neck region. It is contemplated that the robot 302 could assistin placement of a graft. The robot's guide tube 314 may serve as amechanism to redirect applied force to be only along the trajectory ofthe drilled channel, even if the actual force is applied is off angle.The robot 302 may channel the force in such a way because of itsrigidity and floor mounting. A driving tool inserted through the guidetube 314 held by the robot 302 may apply force only in the direction ofthe channel 14, even if struck off-angle by the surgeon, since theforces directed in other axes may be absorbed by the robot arm 303, 304.As described above, the driving tool inserted through the guide tube 314can utilize the proximal end of the guide tube 314 as a depth stop,preventing the surgeon from inadvertently driving the implant 20 toodeep.

One skilled in the art will appreciate that the embodiments discussedabove are non-limiting. While devices may be described as suitable for aparticular location (e.g., vertebra) or approach, one skilled in the artwill appreciate that the devices, instruments, and methods describedherein can be used for multiple locations and approaches. In addition tothe devices, instruments, and methods described above, one skilled inthe art will appreciate that these described features can be used with anumber of other implants and instruments, including fixation plates,rods, fasteners, and other orthopedic devices. It will also beappreciated that one or more features of one embodiment may be partiallyor fully incorporated into one or more other embodiments describedherein.

What is claimed is:
 1. A transcorporeal microdecompression systemcomprising: a plug extending from an upper end to a lower end and a sidewall extending between the upper end and the lower end, the side walltapering between the upper end and the lower end, the lower endconfigured to be inserted into an opening in a vertebra, the upper endhaving an insertion tool interface for securing attaching to aninserter.
 2. The system of claim 1, wherein the plug conically tapersfrom the upper end to the lower end.
 3. The system of claim 2, whereinthe plug conically tapers at three degrees relative to a central axis ofthe plug.
 4. The system of claim 1, wherein the plug includes a graftwindow extending through the side wall to define a through opening. 5.The system of claim 1, wherein the insertion tool interface includes anopening extending from the upper end to an inferior surface, the openingtapering from the inferior surface towards the upper end.
 6. The systemof claim 5, further comprising the inserter having: an outer sleeve; amiddle sleeve terminating in a tip, the middle sleeve positioned withinthe outer sleeve; an inner shaft positioned within the middle sleeve;and an actuator configured to move the middle sleeve axially along alength of the inserter, wherein the tip is configured to mate with theopening in the plug such that when the actuator pushes the middle sleeveforward, the tip is compressed, but when moved back, the inner shaftforces the tip outward, thereby mating with the opening of the plug. 7.The system of claim 1, further comprising a uniplanar drill guideadapted to move and lock at a selected angle within a single planerelative to the vertebra.
 8. The system of claim 7, further comprising arobotic navigation system configured to determine the selected angle forthe uniplanar drill guide.
 9. The system of claim 7, wherein theuniplanar drill guide has a base with a tooth array, a fastenerconfigured to temporarily secure the base to the vertebra, a guide tubemovable relative to the base, the guide tube having a central lumenconfigured to guide an instrument to create or access the channel in thevertebra, wherein movement of the guide tube is controllable by anactuation mechanism having a rotating lock arm with a cam surface and aselector pin movable by the cam surface, wherein the selector pin isconfigured to engage with one or more teeth of the tooth array on thebase to thereby lock an angle of the guide tube.
 10. The system of claim9, wherein the tip of the inserter and the opening in the upper end ofthe plug form a circular dovetail joint.
 11. A transcorporealmicrodecompression system comprising: an inserter; a plug extending froman upper end to a lower end and a circumferential side wall conicallytapering from the upper end to the lower end, the lower end configuredto be inserted into an opening in a vertebra, the upper end having aninsertion tool interface for securing attaching to the inserter; and auniplanar drill guide adapted to move and lock at a selected anglewithin a single plane relative to the vertebra.
 12. The system of claim11, wherein the plug conically tapers at three degrees relative to acentral axis of the plug.
 13. The system of claim 11, wherein the plugincludes a graft window extending through the side wall to define alateral through opening.
 14. The system of claim 11, wherein theinsertion tool interface includes an opening extending from the upperend to an inferior surface, the opening tapering from the inferiorsurface towards the upper end.
 15. The system of claim 11, wherein theinserter includes: an outer sleeve; a middle sleeve terminating in atip, the middle sleeve positioned within the outer sleeve; an innershaft positioned within the middle sleeve; and an actuator configured tomove the middle sleeve axially along a length of the inserter, whereinthe tip is configured to mate with the opening in the plug such thatwhen the actuator pushes the middle sleeve forward, the tip iscompressed, but when moved back, the inner shaft forces the tip outward,thereby mating with the opening of the plug.
 16. The system of claim 11,further comprising a robotic navigation system configured to determinethe selected angle for the uniplanar drill guide.
 17. The system ofclaim 11, wherein the uniplanar drill guide has a base with a tootharray, a fastener configured to temporarily secure the base to thevertebra, a guide tube movable relative to the base, the guide tubehaving a central lumen configured to guide an instrument to create oraccess the channel in the vertebra, wherein movement of the guide tubeis controllable by an actuation mechanism having a rotating lock armwith a cam surface and a selector pin movable by the cam surface,wherein the selector pin is configured to engage with one or more teethof the tooth array on the base to thereby lock an angle of the guidetube.
 18. The system of claim 17, wherein the tip of the inserter andthe opening in the upper end of the implant form a circular dovetailjoint.
 19. The system of claim 11, wherein the plug is a bone void plugmade of allograft.
 20. The system of claim 11, further comprising arobot adapted to determine a pre-planned angle for the guide tube usingone or more pre-operative CT scans.